Early Safety Profile Using Pulsed Field Ablation: Prospective Multicenter DISRUPT-AF Study.

BACKGROUND

Pentaspline pulsed field ablation (PFA) is an emerging technology delivering ultra-short bursts of ablative high electrical field energy. There are limited studies on atrial fibrillation (AF) ablation safety using PFA in real-world experience in the United States.

OBJECTIVES

The study sought to evaluate safety in patients who underwent AF ablation with a pentaspline PFA catheter in a multicenter registry.

METHODS

Patients from the prospective, multicenter, nonrandomized, rigorously monitored, real-world DISRUPT-AF (A registry Based Collaborative To Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF) registry (NCT06335082), who underwent first-time AF ablation via PFA using the pentaspline catheter, from April 2024 to May 2025, across 20 centers in the United States, encompassing 77 operators, were included. Baseline characteristics and acute procedural safety outcomes were collected at 1- and 3-month follow-up based on the investigator's arm: acute, symptomatic monitoring only, or full monitoring. The primary safety outcome comprised procedure/device-related adverse events (AEs) after 1 and 3 months. Risk-adjusted analyses were conducted to assess AE predictors.

RESULTS

A total of 1,576 patients were included: the mean age was 68.0 ± 11.4 years, 38.6% were female, and mean body mass index was 31.5 ± 7.0 kg/m2. At 3-month follow-up, AEs occurred in 2.2% of patients, with 1.6% classified as procedure/device related. The most common AEs were vascular access complications (pseudoaneurysm, 0.4%; hematoma, 0.3%), pericarditis (0.2%), and other nonspecific events (eg, hypotension 0.4%). Major procedure/device-related AEs occurred in 0.7% of patients and included stroke (0.3%), cardiac tamponade (0.1%), vascular injury requiring intervention (0.1%), and bleeding (0.1%). There were no cases of esophageal injury, persistent phrenic nerve injury, or pulmonary vein stenosis. There was 1 (0.06%) case reported as coronary vasospasm, and acute kidney injury was not observed. The 3-month all-cause mortality rate was 0.3%. In exploratory multivariable analyses, no associations were detected between clinical covariates and procedure/device-related AEs.

CONCLUSIONS

In this multicenter, prospective U.S. registry, PFA demonstrated a low rate of procedure/device-related AEs. The absence of injury to the esophagus, phrenic nerve, and pulmonary veins highlights a tissue-selective profile that may represent a meaningful safety advantage over traditional thermal ablation, pending further direct comparisons.